Engineering Plastics for Medical SolutionsUltraform® PRO (POM) and Ultradur ® PRO (PBT )

Further information on individual products: www.plasticsportal.eu/ultraform www.ultradur.de www.plasticsportal.eu/medical

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PRO – Engineering plastics for applications in medical technology ..............................................................03

PRO Service Package – reliability and partnership in a demanding market .................................................05

Ultraform® PRO (POM) – plastics for mechanical and tribological stress .....................................................06

Ultradur® PRO (PBT) – plastics for high precision requirements and dimensional stability ...........................09

PRO grades for tribologically stressed functional parts ................................................................................ 11

Further material properties ............................................................................................................................. 12

Annotation ...................................................................................................................................................... 13

Product overview ............................................................................................................................................ 14

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PRO – Engineering plastics for applications in medical technology

Increasing customer demands in sophisti-

cated medical applications with high-per-

formance profiles and long-term formulation

consistency, prompted BASF to extend its

portfolio of engineering plastics for medical

technology.

BASF customers can reliably offer their pro-

ducts in this demanding market only if the

formulation remains unchanged over a long-

term period. This is especially important as

the medical technology market is character-

ized by long development efforts and costly

approval procedures. Materials that have

demonstrated their reliability in comprehen-

sive testing are essential for the production

of safe drug delivery systems and other

medical devices. This is why BASF’s PRO

products are an important link in the value

chain – from the plastic raw material all the

way to safe products for patients.

The PRO grades are adapted specifically for

these requirements and needs of the medical

technology industry. The suffix PRO (Profile

covered Raw materials Only) expresses the

claim that only very specific raw materials

that are subject to strict controls are used.

It points to an expanded service package for

medical technology. The PRO service pack-

age offers evidence of and compliance with

relevant stipulated international standards

and tests regulating the use of plastics in

medical and pharmaceutical applications.

All the materials covered in the PRO portfolio

are in compliance with the regulations / recom-

mendations or test requirements given in

table 1 (approvals for natural or uncolored

base materials respectively).

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Table 1: Regulations /recommendations or test requirements that the PRO grades are in compliance with

Pharmaceutical and medical applications

EU Pharmacopeia (EP 8th Edition, Chapter 3.2.2 “Plastic Containers and Closures for Pharmaceutical Use”) basic requirements

Japanese Pharmacopeia (16th Edition, General Information, “G7 Plastic Containers for Pharmaceutical Products”) basic requirements

US Pharmacopeia ( USP Biological Reactivity Test Class VI )

Biocompatibility (Cytotoxicity according to ISO 10993-5)

Drug Master File (DMF )

Commission Regulation (EU) No. 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food as amended

Commission Regulation (EU) No. 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food

21 CFR Food Additive Regulations (FDA Compliance) FDA Regulation 21 CFR § 177.2470

“Polyoxymethylene copolymer” FDA Regulation 21 CFR § 177.1660

“Poly (tetramethylene terephthalate)”

Heavy Metals (CONEG (Coalition of North Eastern Governors) for the January 1, 1994, EU Directive 94/62/EEC on heavy metals, EU Directive 2000/53/EC on end-of life vehicles as amended

BSE / TSE Transmittance (no risk materials are used in the produc- tion, monomers / ingredients are of petro-chemical origin, additives from animal origin are in accordance with note for guidance EMEA /410 /01 Rev. 03 adopted by the CPMP (Committee for Pro-prietary Medicinal Products) and CVMP (Committee for Veterinary Medicinal Products). In addition the treatment exceeds the require- ments of the directive 2000 /6 / EG Annex II

Others

Food contact applications

BASF offers, for example, preliminary experiments

on chemical compatibility as well as biocompati-

bility tests, which are already performed on the pel-

lets. Extraction studies conducted by independent

external institutes also show the quality of the PRO

grades. By supplying these certified plastics, BASF

helps its customers to obtain approval for the final

product and so supports long-term patient safety.

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The extended PRO Service Package comprises:

Documented intention not to change the plas-tic formulation (as lodged /defined in the Drug Master File DMF ) in the long-term, except for necessary adjustments and external con-straints respectively due to regulatory changes or amendments to general legal framework

Guarantee to inform customers at least 36 months in advance of any unavoidable chang-es to resin formulations (as lodged /defined in the Drug Master File (DMF))

Support of worldwide approvals for pharma-ceutical and medical applications as well as for food contact

Testing the compatibility of the plastic to specific chemicals

Production conditions according to GMP ( good manufacturing practices) principles Commission Regulation ( EC ) 2023 /2006

Application technology support ( processing, design, calculation)

PRO Service Package – reliability and partnership in a demanding market

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Ultraform® PRO (POM) – plastics for mechanical and tribological stress

Fig. 1: Availability of Ultraform® PRO: first letter indicates melt viscosity (MVR)

MFR

= M

VR *

mel

t den

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; mel

t den

sity

of u

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nfor

ced

grad

es a

t 190

°C: 1

.175

g /c

m3

Ultraform® ( POM, polyoxymethylene) is a semi-

crystalline copolymeric engineering plastic.

Ultraform® is highly resistant to diverse chemi-

cals. The good hydrolysis resistance as well as

the dimensional stability under heat ensure that

components made of Ultraform® are suitable for

sterilization procedures like superheated steam,

plasma and ethylene oxide. Products made of

Ultraform® especially stand out for their smooth

and hard surface. Moreover, Ultraform® can with-

stand mechanical stress very well and shows

excellent friction and wear behavior. Due to the

combination of outstanding resilience and sliding

behavior Ultraform® is highly suitable for the pro-

duction of functional components such as valves,

plugin connectors, gearwheels and spring elements.

The six Ultraform® PRO grades show a wide range

of flowability ( from 2.2 to 25 cm³/10 min), covering

the requirements for extrusion (stock shapes) and

injection molding from thick-walled parts up to

thinwalled parts with long flow paths.

thick-walled parts thin-walled parts

Extrusion Injection Molding

H4320 PRO W2320 003 PRO

H

2.2

N2320 003 PRO

N

7.5

S2320 003 PRO

S

11

W

25

W2320 003 PRO TR

W

25

MVR

(190

°C/2

.16

kg) [

cm³/

10m

in]

30

25

10

15

20

5

0

13

S

S2320 003 PRO TR

Standard Lubricated

Ultraform® S2320 003 PRO is a standard flowing

and rapidly freezing grade suitable for standard

functional applications. In contrast, Ultraform®

W2320 003 PRO is a very easy flowing grade for

thin-walled components with long flow paths.

Both Ultraform® S2320 003 PRO and Ultraform®

W2320 003 PRO are predestined for components

where high stiffness and simultaneously an out-

standing resilience are required. Ultraform®

S2320 003 PRO TR and Ultraform® W2320 003

PRO TR are injection molding grades with good

flowability, including a special lubricant to minimize

squeaking and slick-slip.

Ultraform® N2320 003 PRO is a rapidly solidifying

grade with enhanced viscosity. It is well suited for

the production of thick-walled components requir-

ing high mechanical strength due to its excellent

impact resistance and stiffness.

The Ultraform® N, S and W PRO grades for injec-

tion molding are suited for the manufacturing of

functional components in insulin pens, atomizing

devices and dry-powder inhalers.

Ultraform® H4320 PRO has been tailored specifi-

cally for extrusion processes. It has even higher

viscosity than the Ultraform® N grade and is more

impact-resistant while also being very stiff as

well as strong. It also shows good thermal stabili-

ty. Its target applications are plug-in connectors,

the handles of surgical instruments and other

components in small production runs that are

made form semi-finished parts.

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8

Properties Possible applications Processing

High crystallinity

Ideal combination of strength, stiffness and toughness

Outstanding tribological properties, i. e. low friction and wear, very good sliding properties

Excellent long-term be-havior, low fatigue under mechanical stress

Very good resilience

Excellent chemical and hydrolysis resistance

Withstands sterilization with hot-steam, plasma and ethylene oxide

Excellent thermal and oxi-dative stability, high resis-tance to heat deflection (continuous temperatures of up to 100 °C )

Good processability

Functional and mechani-cal components with high dimensional precision and stability for use in medical devices such as insulin pens, inhalers or atomising systems

Device components such as spring elements, snap-fits, gearwheels, bearings, sleeves, valves or nozzles

Tribological systems such as cylinders, screws, slid-ers or nuts

Clamps for inner tubes, clips or plug-in connectors

Pharmaceutical closures

Handles for surgical instru-ments

Transmission and connect-ing elements for conveyor chains and belts

Injection Molding

Extrusion

Table 2: Ultraform® PRO at a glance

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Ultradur® PRO (PBT ) – plastics for high precision requirements and dimensional stability

BASF Ultradur® (PBT, polybutylene terephthalate)

is a semi-crystalline engineering plastic, which is

part of the polyester family of resins. Among the

many features of Ultradur® are outstanding

mechanical properties like rigidity and strength

combined with excellent heat aging behavior.

Depending on the friction partner, Ultradur® shows

excellent sliding behavior. Ultradur® can be easily

processed by injection molding due to its good

flow properties. Short cycle times can be achieved.

Ultradur® B4520 PRO is suited for injection mold-

ing applications in medical technology. The

Ultradur® B4520 PRO grade offers the combina-

tion of high dimensional stability with a uniform

shrinkage behavior. Products made from Ultradur®

B4520 PRO are able to meet the strict require-

ments of dimensional component accuracy

intended for medical devices. Other advantages

of this material are low water absorption under

standard use conditions for medical devices

as well as high resistance to many chemicals.

Ultradur® B4520 PRO can be easily printed using

hot stamping as well as pad printing processes

and sterilised with ionizing (gamma) radiation or

ethylene oxide. Ultradur® B4520 PRO TR is a new

tribological grade with improved friction, sliding

and wear properties.

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Properties Possible applications Processing

High reproducibility accu-racy plus high dimensional stability due to im proved shrinking behavior

Broad chemical resistance to polar and non-polar sol- vents

Low water /moisture ab-sorption

Ideal sliding, due to high friction and wear resis-tance (depending on the sliding partner)

Very good printability (can be decorated using the hot stamping and pad printing processes)

Excellent heat aging be-havior

Retains its property pro-file on exposure to ioniz-ing radiation and ethylene oxide

Good moldability with fast cycles

Functional and mechani-cal components with high dimensional precision and stability for use in drug delivery systems such as insulin pens, inhalers or metering devices

Device components such as manifolds, screws, sleeves, valves, plungers, lancets or caps

Chassis and housings

Filter systems

Drug containers

Pharmaceutical closures

Technical disposable applications

Injection Molding

Extrusion

Table 3: Ultradur® PRO at a glance

PRO grades for tribologically stressed functional parts

Tribological pairing of components made of

Ultraform® PRO and Ultradur® PRO offers addi-

tional benefits. For instance, insulin pens with

excellent sliding friction properties can be

produced in combination with these materials.

Ultraform® is making a contribution to lower the

friction between the contacting functional parts,

and Ultradur® is acting as a slip /sliding partner

reducing annoying noises during operation.

Good results in terms of friction, wear resistance

and reduced noise emissions will also be achieved

with the combination of Ultradur® B4520 PRO

and every Ultraform® PRO grade.

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Further material properties

Fig. 2: Long-term chemical resistance of Ultraform® PRO and Ultradur® PRO

Alip

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Aro

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Alk

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Est

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Org

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Ultraform® PRO (POM) + + + 2 + + + 4 + 6 o 8 +

Ultradur® PRO (PBT ) + + 1 o 3 + + + 5 o 7 + +

1 limited resistance: possible strong swelling at elevated

temperatures

2 limited resistance: soda lye, ammonia water, carbamide solution, amine

3 limited resistance: weakly alkaline media: carbamide solution, soda lye pH 10

non-resistant: strongly alkaline media: soda lye pH 14

4 limited resistance: > 60 °C ethanol, methanol & isopropanol

5 limited resistance: > 40 °C ethanol, methanol & isopropanol

6 limited resistance: chlorinated drinking water, acidic /oxidising solutions

7 limited resistance: 40 -90 °C ( humidity)

non-resistant: > 90 °C ( humidity)

8 limited resistance: aqueous dilution acetic acid, formic acid, citric acid, benzoic acid

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Fig. 3: Resistance to sterilisation of Ultraform® PRO and Ultradur® PRO

Superheated steam Irradiation Gas

Plasma121 °C 134 °C 143 °C Gamma

Electron

beam

Ethylene

Oxide

Ultraform® PRO + o* -* o o + +

Ultradur® PRO o* -* -* + + + o

+ = resistant o = limited resistance - = non-resistant* Superheated steam resistance is dependent on conditions duration and number of cycles

All materials used in medical technology must meet specific purification requirements regarding chemical

resistance and resistance to sterilisation. The figures 2 and 3 give an overview about the resistance against

typical cleaning additives and purification methods.

+ = resistant o = limited resistance

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BASF produces a wide variety of high quality ma- terials that satisfy the manifold requirements of our customers, including products that may meet the technical specifications for use in medical devices and pharmaceutical applications. BASF has proven expertise in supporting and working with our cus-tomers in the innovative use and application of our materials.

However, BASF has not designed or tested its plas-tics with respect to all of the special requirements related to their use in medical devices (defined in risk classes I to III according to the European and US Medical Device legislation) and pharmaceutical applications. Therefore BASF makes no warranties, express or implied, concerning the suitability of any BASF plastics for use in any medical device and pharmaceutical applications. Please inform us in advance, if you intend to use BASF plastics in medi-cal devices or pharmaceutical applications.

BASF does not supply its plastics for the manufac-ture of implants in any risk class. BASF expressively advises against plastics supplied for other purposes being used for these medical applications.

Subject to an evaluation and a release in each indi-vidual case BASF is prepared to supply plastics for

medical applications within risk class I or for phar-maceutical applications such as solid dosage forms for oral applications. Provided an agreement can be reached which takes into account the circumstances of each individual case and a disclaimer is accepted by the customer BASF is prepared to supply plastics for individual medical applications within risk class II (with the exception of implants) including packag-ing of parenteral and ophthalmic products as well as inhalers.

Should a customer wish to use BASF plastics in ap-plications within risk class III, which are not implants, sale is possible only in very exceptional cases at the special request of the customer. However, a detailed risk assessment has to be provided.

In all cases the BASF customer has to establish from their own experience and from tests on BASF plastics, that these plastics are suitable for the manufacture of products for medical applications or pharmaceutical applications (with the exception of implants) includ-ing packaging of parenteral and ophthalmic products as well as inhalers. The customer has also to ensure that the medical device or pharmaceutical application manufactured using BASF plastics is safe, lawful and technically suitable for the intended use.

Annotation

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Typical values for uncolored products at 23 °C

Unit

Test method

Ultraform® H4320 PRO

Ultraform® N2320 003 PRO

Ultraform® S2320 003 PRO

Ultraform® S2320 003 PRO TR

Ultraform® W2320 003 PRO

Ultraform® W2320 003 PRO TR

Ultradur® B4520 PRO

Ultradur® B4520 PRO TR

PropertiesPolymer abbreviation – – POM POM POM POM POM POM PBT PBTDensity kg / m3 ISO 1183 1,390 1,400 1,400 1,400 1,400 1,370 1,300 1,300Melt volume rate MVR* cm³/ 10 min ISO 1133 2.2 7.5 11 13 25 25 25 21Melt flow rate MFR (190 °C / 2.16 kg) g / 10 min 2.6 8.8 13 – 29.4 29 – –Reinforcing material – – without without without without without without without withoutWater absorption, equilibrium in water at 23 °C % similar to ISO 62 0.8 0.8 0.8 0.8 0.8 0.8 0.5 0.5Moisture absorption, equilibrium 23 °C / 50 % r. h. % similar to ISO 62 0.2 0.2 0.2 0.2 0.2 0.2 0.25 0.25ProcessingProcessing: Injection molding ( M ), Extrusion ( E ), Blow molding ( B )

– – M, E M M M M M M, (E) M, (E)

Pre-drying temperature °C – 100** 100** 100** 100** 100** 100** 80 - 120 80 - 120Pre-drying time h – 3** 3** 3** 3** 3** 3** 4 4Max. residual moisture content % – 0.2** 0.2** 0.2** 0.2** 0.2** 0.2** 0.04 0.04Melt temperature, injection molding, range °C – 190 - 230*** 190 - 230 190 - 230 190 - 230 190 - 230 190 - 230 250 - 270 250 - 270Mold temperature, injection molding, range °C – 60 - 120 60 - 120 60 - 120 60 - 120 60 - 120 60 - 120 40 - 70 40 - 70Molding shrinkage ( parallel ) % ISO 2577, 294 - 4 2.2 2.1 2.1 2.2 2.0 2.1 2.1 2.1Molding shrinkage ( normal ) % ISO 2577, 294 - 4 2.1 2.1 2.1 2.0 2.1 2.1 2.5 2.5Mechanical PropertiesTensile modulus MPa ISO 527-1 /-2 2,600 2,700 2,700 2,600 2,800 2,500 2,600 2,600Yield stress, 50 mm / min MPa ISO 527-1 /-2 63 65 65 62 65 50 60 55Yield strain, 50 mm / min % ISO 527-1 /-2 10 9.4 9 9 7.5 5 10.8 3.3Nominal strain at break, 50 mm / min % ISO 527-1 /-2 31 27 28 35 24 35 30 30Tensile creep modulus ( 1 h) MPa ISO 899 -1 1,800 1,800 1,900 – 2,100 1,850 1,800 –Tensile creep modulus ( 1,000 h) MPa ISO 899 -1 1,300 1,400 1,300 – 1,350 1,100 1,200 –Charpy unnotched impact strength ( 23 °C ) kJ / m2 ISO 179 / 1eU 250 210 180 180 150 100 228 184Charpy unnotched impact strength (- 30 °C ) kJ / m2 ISO 179 / 1eU 180 190 170 145 150 110 140 168Charpy notched impact strength ( 23 °C ) kJ / m2 ISO 179 / 1eU 6 6 5.5 5.5 5 4 4.5 3.6Charpy notched impact strength (- 30 °C ) kJ / m2 ISO 179 / 1eU 5.5 5.5 5 6 4 4 3 4Ball indentation hardness at 358 N and 30 s MPa ISO 2039 -1 125 145 145 – 145 125 130 120Thermal PropertiesMelting temperature, DSC (20 °C / min ) °C ISO 11357-1/-3 166 167 167 167 167 167 223 223HDT A (1.80 MPa ) °C ISO 75-1 /-2 95 100 100 100 100 90 55 58HDT B (0.45 MPa ) °C ISO 75-1 /-2 155 156 156 – 156 – 165 145Vicat softening temperature (50 °C / h, 50 N) °C ISO 306 150 150 150 – 150 – – –Max. service temperature (short cycle operation) °C – 100 100 100 100 100 90 200 200Coefficient of linear thermal expansion, longitudinal ( 23 - 55 °C ) 10- 6 / K ISO 11359 -1 /-2 120 110 110 120 110 125 145 –Compliance – pharmaceutical / medical USP Class VI Yes Yes Yes Yes Yes Yes Yes YesCytotoxicity ( ISO 10993-5) Yes Yes Yes Yes Yes Yes Yes YesDrug Master File ( DMF ) 24606 24607 19888 26560 19889 26560 24605 –Compliance – food contactEuropean Food Contact Regulations: Commission Regulation (EU) No 10 /2011

Yes Yes Yes Yes Yes Yes Yes Yes

US FDA Regulations: 21 CFR and /or Food Contact Notifications § 177.2470 § 177.2470 § 177.2470 § 177.2470 § 177.2470 § 177.2470 § 177.1660 § 177.1660

* Melt volume-flow rate MVR according to ISO 1133: Ultraform® PRO: 190 °C and 2.16 kg Ultradur ® PRO: 250 °C and 2.16 kg

** Granules or pellets of Ultraform® PRO in original packaging can be processed without any special pre-treatment. Granules or pellets which have become moist due to prolonged or incorrect storage (e. g. by formation of condensed water ) must be dried in dehumidifying or re-circulating air dryers according to the above recommended conditions.

*** Melt temperature, extrusion: 175-180 °C

Engineering Plastics for Medical SolutionsUltraform® PRO (POM) and Ultradur ® PRO (PBT )

Engineering Plastics for Medical SolutionsUltraform® PRO (POM) and Ultradur® PRO (PBT )

15

Typical values for uncolored products at 23 °C

Unit

Test method

Ultraform® H4320 PRO

Ultraform® N2320 003 PRO

Ultraform® S2320 003 PRO

Ultraform® S2320 003 PRO TR

Ultraform® W2320 003 PRO

Ultraform® W2320 003 PRO TR

Ultradur® B4520 PRO

Ultradur® B4520 PRO TR

PropertiesPolymer abbreviation – – POM POM POM POM POM POM PBT PBTDensity kg / m3 ISO 1183 1,390 1,400 1,400 1,400 1,400 1,370 1,300 1,300Melt volume rate MVR* cm³/ 10 min ISO 1133 2.2 7.5 11 13 25 25 25 21Melt flow rate MFR (190 °C / 2.16 kg) g / 10 min 2.6 8.8 13 – 29.4 29 – –Reinforcing material – – without without without without without without without withoutWater absorption, equilibrium in water at 23 °C % similar to ISO 62 0.8 0.8 0.8 0.8 0.8 0.8 0.5 0.5Moisture absorption, equilibrium 23 °C / 50 % r. h. % similar to ISO 62 0.2 0.2 0.2 0.2 0.2 0.2 0.25 0.25ProcessingProcessing: Injection molding ( M ), Extrusion ( E ), Blow molding ( B )

– – M, E M M M M M M, (E) M, (E)

Pre-drying temperature °C – 100** 100** 100** 100** 100** 100** 80 - 120 80 - 120Pre-drying time h – 3** 3** 3** 3** 3** 3** 4 4Max. residual moisture content % – 0.2** 0.2** 0.2** 0.2** 0.2** 0.2** 0.04 0.04Melt temperature, injection molding, range °C – 190 - 230*** 190 - 230 190 - 230 190 - 230 190 - 230 190 - 230 250 - 270 250 - 270Mold temperature, injection molding, range °C – 60 - 120 60 - 120 60 - 120 60 - 120 60 - 120 60 - 120 40 - 70 40 - 70Molding shrinkage ( parallel ) % ISO 2577, 294 - 4 2.2 2.1 2.1 2.2 2.0 2.1 2.1 2.1Molding shrinkage ( normal ) % ISO 2577, 294 - 4 2.1 2.1 2.1 2.0 2.1 2.1 2.5 2.5Mechanical PropertiesTensile modulus MPa ISO 527-1 /-2 2,600 2,700 2,700 2,600 2,800 2,500 2,600 2,600Yield stress, 50 mm / min MPa ISO 527-1 /-2 63 65 65 62 65 50 60 55Yield strain, 50 mm / min % ISO 527-1 /-2 10 9.4 9 9 7.5 5 10.8 3.3Nominal strain at break, 50 mm / min % ISO 527-1 /-2 31 27 28 35 24 35 30 30Tensile creep modulus ( 1 h) MPa ISO 899 -1 1,800 1,800 1,900 – 2,100 1,850 1,800 –Tensile creep modulus ( 1,000 h) MPa ISO 899 -1 1,300 1,400 1,300 – 1,350 1,100 1,200 –Charpy unnotched impact strength ( 23 °C ) kJ / m2 ISO 179 / 1eU 250 210 180 180 150 100 228 184Charpy unnotched impact strength (- 30 °C ) kJ / m2 ISO 179 / 1eU 180 190 170 145 150 110 140 168Charpy notched impact strength ( 23 °C ) kJ / m2 ISO 179 / 1eU 6 6 5.5 5.5 5 4 4.5 3.6Charpy notched impact strength (- 30 °C ) kJ / m2 ISO 179 / 1eU 5.5 5.5 5 6 4 4 3 4Ball indentation hardness at 358 N and 30 s MPa ISO 2039 -1 125 145 145 – 145 125 130 120Thermal PropertiesMelting temperature, DSC (20 °C / min ) °C ISO 11357-1/-3 166 167 167 167 167 167 223 223HDT A (1.80 MPa ) °C ISO 75-1 /-2 95 100 100 100 100 90 55 58HDT B (0.45 MPa ) °C ISO 75-1 /-2 155 156 156 – 156 – 165 145Vicat softening temperature (50 °C / h, 50 N) °C ISO 306 150 150 150 – 150 – – –Max. service temperature (short cycle operation) °C – 100 100 100 100 100 90 200 200Coefficient of linear thermal expansion, longitudinal ( 23 - 55 °C ) 10- 6 / K ISO 11359 -1 /-2 120 110 110 120 110 125 145 –Compliance – pharmaceutical / medical USP Class VI Yes Yes Yes Yes Yes Yes Yes YesCytotoxicity ( ISO 10993-5) Yes Yes Yes Yes Yes Yes Yes YesDrug Master File ( DMF ) 24606 24607 19888 26560 19889 26560 24605 –Compliance – food contactEuropean Food Contact Regulations: Commission Regulation (EU) No 10 /2011

Yes Yes Yes Yes Yes Yes Yes Yes

US FDA Regulations: 21 CFR and /or Food Contact Notifications § 177.2470 § 177.2470 § 177.2470 § 177.2470 § 177.2470 § 177.2470 § 177.1660 § 177.1660

* Melt volume-flow rate MVR according to ISO 1133: Ultraform® PRO: 190 °C and 2.16 kg Ultradur ® PRO: 250 °C and 2.16 kg

** Granules or pellets of Ultraform® PRO in original packaging can be processed without any special pre-treatment. Granules or pellets which have become moist due to prolonged or incorrect storage (e. g. by formation of condensed water ) must be dried in dehumidifying or re-circulating air dryers according to the above recommended conditions.

*** Melt temperature, extrusion: 175-180 °C

Engineering Plastics for Medical SolutionsUltraform® PRO (POM) and Ultradur ® PRO (PBT )

PM

EI 1

507

BE

Selected Product Literature for Ultradur® and Ultraform®:

Ultradur® – Product Brochure Ultradur® – Product Range Ultraform® – Product Brochure Ultraform® – Product Range Ultramid®, Ultradur® and Ultraform® – Resistance to Chemicals

Note

The data contained in this publication are based on our current knowledge and

experience. In view of the many factors that may affect processing and application

of our product, these data do not relieve processors from carrying out own investi-

gations and tests; neither do these data imply any guarantee of certain properties,

nor the suitability of the product for a specific purpose. Any descriptions, drawings,

photographs, data, proportions, weights etc. given herein may change without prior

information and do not constitute the agreed contractual quality of the product. It

is the responsibility of the recipient of our products to ensure that any proprietary

rights and existing laws and legislation are observed. ( November 2015 )

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Please visit our websites:

www.plasticsportal.com ( World )

www.plasticsportal.eu ( Europe )

Additional information on specific products:

www.plasticsportal.eu /name of product

e. g. www.plasticsportal.eu /ultraform

Request of brochures:

PM / K, F 204

Fax: + 49 621 60 - 49497

If you have technical questions on the products,

please contact the Ultra-Infopoint: